Medical Device Manufacturer · AU , Sydney

Annalise-Ai - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2022

Recent clearances: Annalise Enterprise, Annalise Enterprise CXR Triage Pneumothorax

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Annalise-Ai Radiology ✕

2 devices

1-2 of 2

Cleared Apr 23, 2025

Annalise Enterprise

Radiology · 35d

Cleared Feb 24, 2022

Annalise Enterprise CXR Triage Pneumothorax

Radiology · 70d